Ovarian CancerDISCOVARNCT01505829
Diffusion-weighted Imaging Study in Cancer of the Ovary
An observational study of Ovarian Cancer and Peritoneal Metastases, run by Institute of Cancer Research, United Kingdom at 6 sites in United Kingdom.
Trial summary
This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Peritoneal Metastases
- How many people
- 134 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Aug 2012to 13 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with primary or relapsed ovarian cancer
Who may be able to join
- Histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage III or IV
- Scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery.
Who cannot join
- Life expectancy of less than 6 months
- MRI contraindications
- Low grade or heavily calcified disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Imperial College Healthcare NHS Trust
London, W6 8RF
Queen Elizabeth Hospital
Newcastle, Gateshead, NE9 6SX
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Singleton Hospital
Swansea, Wales, SA2 8QA
About this study
Official title: Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.
This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.
- Conditions
- Ovarian Cancer, Peritoneal Metastases
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biological validation cohort 1 | Not described | |
| Response assessment cohort 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response.
Diffusion-weighted magnetic resonance imaging (DW-MRI) for visualising peritoneal metastases will be developed.Reproducibility will be assessed in a multi-centre setting across multiple vendor platforms and field strengths by comparing 2 baseline scans per person and plotting absolute difference in ADC against mean of the 2 measurements.Biological validation will be achieved by correlating scan data (ADC change) following chemotherapy with histology of the tumour(amount of cell death) at surgery.
Measured: 4.0 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2016
- Study completion13 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Royal Marsden NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Northumbria Healthcare NHS Foundation Trust, East and North Hertfordshire NHS Trust
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita deSouza, Professor, Principal investigator, ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505829
- Sponsor's protocol ID
- 11/LO/1598 CCR3694
- Other IDs
- C1353/A12762
- Acronym
- DISCOVAR
- Status last verified
- Jan 2020
- First submitted
- 18 Nov 2011
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Winfield JM, Wakefield JC, Brenton JD, AbdulJabbar K, Savio A, Freeman S, Pace E, Lutchman-Singh K, Vroobel KM, Yuan Y, Banerjee S, Porta N, Ahmed Raza SE, deSouza NM. Biomarkers for site-specific response to neoadjuvant chemotherapy in epithelial ovarian cancer: relating MRI changes to tumour cell load and necrosis. Br J Cancer. 2021 Mar;124(6):1130-1137. doi: 10.1038/s41416-020-01217-5. Epub 2021 Jan 4.
PubMed 33398064
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.
- ClinicalTrials.gov ID
- NCT01505829
- Acronym / sponsor ID
- DISCOVAR / 11/LO/1598 CCR3694
- Conditions
- Ovarian Cancer, Peritoneal Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK, Royal Marsden NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Northumbria Healthcare NHS Foundation Trust, East and North Hertfordshire NHS Trust
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 13 Oct 2018 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological validation cohort 1 | – | – |
| Response assessment cohort 2 | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or relapsed ovarian cancer
Key inclusion criteria (2 listed)
- Histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage III or IV
- Scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery.
Key exclusion criteria (3 listed)
- Life expectancy of less than 6 months
- MRI contraindications
- Low grade or heavily calcified disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response.
Time frame: 4.0 years
Diffusion-weighted magnetic resonance imaging (DW-MRI) for visualising peritoneal metastases will be developed.Reproducibility will be assessed in a multi-centre setting across multiple vendor platforms and field strengths by comparing 2 baseline scans per person and plotting absolute difference in ADC against mean of the 2 measurements.Biological validation will be achieved by correlating scan data (ADC change) following chemotherapy with histology of the tumour(amount of cell death) at surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 33398064Winfield JM, Wakefield JC, Brenton JD, AbdulJabbar K, Savio A, Freeman S, Pace E, Lutchman-Singh K, Vroobel KM, Yuan Y, Banerjee S, Porta N, Ahmed Raza SE, deSouza NM. Biomarkers for site-specific response to neoadjuvant chemotherapy in epithelial ovarian cancer: relating MRI changes to tumour cell load and necrosis. Br J Cancer. 2021 Mar;124(6):1130-1137. doi: 10.1038/s41416-020-01217-5. Epub 2021 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandita deSouza, Professor principal investigator
ICR
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Peritoneal Metastases, run by Institute of Cancer Research, United Kingdom at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response. (time frame: 4.0 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.